Dorzolamide/Brimonidine/Timolol Impact on Ocular Surface, Glaucoma Progression & Chatbot Follow-up: GLAUCO-TECH (GLAUCO-TECH)
GLAUCO-TECH Study: Safety & Efficacy of Preservative-free vs. Preserved Dorzolamide-Timolol-Brimonidine. Impact on the Ocular Surface, Glaucoma Progression, Tear Proteomics, and AI/Chatbot-led Patient Follow-up.
The primary objective of this study is to evaluate the ocular surface safety of an ophthalmic solution indicated for the management of glaucoma, containing the active ingredients dorzolamide, timolol, and brimonidine, in patients diagnosed with primary open-angle glaucoma. The most relevant questions to be answered by this study are:
In patients with ocular hypertension or open-angle glaucoma, does treatment with the preservative-free dorzolamide-timolol-brimonidine combination improve ocular surface health?
Will there be differences in treatment adherence between patients with ocular hypertension or open-angle glaucoma using a preservative-free dorzolamide-timolol-brimonidine combination versus a combination with preservatives?
Will there be differences in therapeutic efficacy between patients with ocular hypertension or open-angle glaucoma when using a preservative-free dorzolamide-timolol-brimonidine combination versus a preservative-containing dorzolamide-timolol-brimonidine combination?
Will there be differences in changes in biomolecular markers on the ocular surface between patients with ocular hypertension or open-angle glaucoma when using a preservative-free dorzolamide-timolol-brimonidine combination versus a preservative-containing dorzolamide-timolol-brimonidine combination?
Researchers will study these differences by comparing a formulation with the dorzolamide, timolol, and brimonidine combination that uses a preservative versus another with the same combination that does not use preservatives. Preservatives are used in ophthalmic solutions to prevent bacterial contamination. New technological developments in bottles allow for solutions without the need for preservatives. Participants must:
- Take their medication according to the investigator's instructions for at least 4 months
- Attend follow-up appointments at the beginning, and every 2 months until 4 months have passed
- Answer phone calls every 15 days
- Complete the quality of life questionnaires within the timeframes defined by the investigator
Обзор исследования
Статус
Подробное описание
A prospective, randomized, comparative, single-blind (masked evaluator) clinical trial will evaluate the preservative-free fixed-dose combination of dorzolamide, timolol, and brimonidine versus the same combination with preservatives in patients diagnosed with primary open-angle glaucoma or ocular hypertension treated in Cali, Colombia.
Adult patients with a clinical indication for topical triple hypotensive therapy, currently receiving treatment with the preservative formulation or in the process of initiating or changing treatment, will be included. Participants will be assigned to one of the two treatment groups and will be followed longitudinally under real-world clinical practice conditions, with standardized measurements.
The primary objective of the study is to compare the impact of both formulations on ocular surface health, integrating objective and subjective measures of dry eye. Secondary objectives include evaluating intraocular pressure control, ocular and systemic safety and tolerability, treatment adherence, vision-related quality of life, and signs of structural and functional glaucomatous progression. In addition, the study incorporates two substudies. The technology substudy will evaluate the effect of an educational chatbot and reminders on patient adherence, disease knowledge, and self-efficacy. The molecular substudy will explore the proteomic profile of the tear film and its variation in response to treatment, in order to identify molecular markers associated with tolerability, ocular surface inflammation, and clinical response.
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 4
Контакты и местонахождение
Места учебы
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Valle del Cauca Department
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Cali, Valle del Cauca Department, Колумбия, 760044
- Clínica Sigma Cali
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria: Age 18 years or older.
- Diagnosis of primary open-angle glaucoma or ocular hypertension, confirmed by the treating ophthalmologist.
- Continuous and stable treatment with a topical fixed-dose combination of dorzolamide, timolol, and brimonidine in a preservative formulation, for a minimum of 3 months and a maximum of 12 months prior to study enrollment.
- No prior use of preservative-free formulations of dorzolamide, timolol, and brimonidine.
- Exclusive use of the fixed-dose combination of dorzolamide, timolol, and brimonidine, without other concomitant ocular hypotensive agents.
- Ability to attend all study visits and procedures.
- Signed written informed consent.
Exclusion Criteria: Patients with any of the following conditions will be excluded:
- History of glaucoma, retinal, or cataract surgery.
- History of corneal refractive surgery (LASIK, PRK, SMILE).
- Diagnosis of secondary glaucoma (neovascular, inflammatory, traumatic, or other secondary causes).
- History of previous iridotomy, iridoplasty, or trabeculoplasty procedures.
- Presence of concomitant ocular diseases that may interfere with the evaluation of the ocular surface (e.g., Sjögren's syndrome, active infectious keratitis, or severe ocular allergy).
- Decompensated systemic conditions that contraindicate the use of topical beta-blockers (uncontrolled asthma, bradycardia, second- or third-degree AV block).
- Pregnancy or breastfeeding.
- Any medical or ophthalmological condition that, in the investigator's judgment, compromises the participant's safety or the validity of the data.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Активный компаратор: Preservative-free dorzolamide-timolol-brimonidine combination
Participants will receive treatment with a combination of brimonidine, timolol, and dorzolamide, one drop every 12 hours for four months.
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At the start of the study, participants will complete quality-of-life questionnaires and undergo clinical follow-up tests.
During the study, they will be randomly assigned to interact with a chatbot during the follow-up phase to compare the impact on treatment adherence.
Studies using ocular surface biomarkers will be conducted before and after the assigned treatment.
Другие имена:
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Другой: Preservative dorzolamide-timolol-brimonidine combination
Participants will receive treatment with a combination of brimonidine, timolol, and dorzolamide, one drop every 12 hours for four months.
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At the start of the study, participants will complete quality-of-life questionnaires and undergo clinical follow-up tests.
During the study, they will be randomly assigned to interact with a chatbot during the follow-up phase to compare the impact on treatment adherence.
Studies using ocular surface biomarkers will be conducted before and after the assigned treatment.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Changes in efficacy and quality of life and adherence questionnaires between two different formulations
Временное ограничение: From enrollment to the end of treatment at 16 weeks
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Are there significant differences in ocular surface health, adherence, quality of life, or clinical effectiveness between patients treated with preservative-free Dorzolamide-Timolol-Brimonidine and those receiving preservative-containing Dorzolamide-Timolol-Brimonidine?
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From enrollment to the end of treatment at 16 weeks
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Carlos Cifuentes, MD, Clinica Sigma
Публикации и полезные ссылки
Общие публикации
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- Weinreb RN, Leung CK, Crowston JG, Medeiros FA, Friedman DS, Wiggs JL, Martin KR. Primary open-angle glaucoma. Nat Rev Dis Primers. 2016 Sep 22;2:16067. doi: 10.1038/nrdp.2016.67.
- Martinez-Perez P, Orozco-Beltran D, Pomares-Gomez F, Hernandez-Rizo JL, Borras-Gallen A, Gil-Guillen VF, Quesada JA, Lopez-Pineda A, Carratala-Munuera C. Validation and psychometric properties of the 8-item Morisky Medication Adherence Scale (MMAS-8) in type 2 diabetes patients in Spain. Aten Primaria. 2021 Feb;53(2):101942. doi: 10.1016/j.aprim.2020.09.007. Epub 2021 Jan 25.
- Jones L, Craig JP, Markoulli M, Karpecki P, Akpek EK, Basu S, Bitton E, Chen W, Dhaliwal DK, Dogru M, Gomes JAP, Koehler M, Mehta JS, Perez VL, Stapleton F, Sullivan DA, Tauber J, Tong L, Trave-Huarte S, Wolffsohn JS; TFOS Collaborator Group. TFOS DEWS III: Management and Therapy. Am J Ophthalmol. 2025 Nov;279:289-386. doi: 10.1016/j.ajo.2025.05.039. Epub 2025 Jun 2.
- Bachhuber F, Huss A, Senel M, Tumani H. Diagnostic biomarkers in tear fluid: from sampling to preanalytical processing. Sci Rep. 2021 May 12;11(1):10064. doi: 10.1038/s41598-021-89514-8.
- Ngo GH, Chadha M, Sun YJ, Yu G, Lee SH, Yeh TC, Almeida DRP, Bassuk AG, Mruthyunjaya P, Dufour A, Mahajan VB. Protocol to extract tear fluid for proteomics using Schirmer strips. STAR Protoc. 2025 Dec 19;6(4):104146. doi: 10.1016/j.xpro.2025.104146. Epub 2025 Oct 16.
- Stapleton F, Argueso P, Asbell P, Azar D, Bosworth C, Chen W, Ciolino JB, Craig JP, Gallar J, Galor A, Gomes JAP, Jalbert I, Jie Y, Jones L, Konomi K, Liu Y, Merayo-Lloves J, Oliveira FR, Perez VL, Rocha EM, Sullivan BD, Sullivan DA, Vehof J, Vitale S, Willcox M, Wolffsohn JS, Dogru M. TFOS DEWS III: Digest. Am J Ophthalmol. 2025 Nov;279:451-553. doi: 10.1016/j.ajo.2025.05.040. Epub 2025 Jun 4.
- Wolffsohn JS, Benitez-Del-Castillo JM, Loya-Garcia D, Inomata T, Iyer G, Liang L, Pult H, Sabater AL, Starr CE, Vehof J, Wang MTM, Chen W, Craig JP, Dogru M, Perez VL, Stapleton F, Sullivan DA, Jones L; + TFOS collaborator group. TFOS DEWS III: Diagnostic Methodology. Am J Ophthalmol. 2025 Nov;279:387-450. doi: 10.1016/j.ajo.2025.05.033. Epub 2025 May 30.
- Benitez-Del-Castillo JM, Burgos-Blasco B. Prevalence of dry eye disease in Spain: A population-based survey (PrevEOS). Ocul Surf. 2025 Apr;36:126-133. doi: 10.1016/j.jtos.2025.01.006. Epub 2025 Jan 17.
- Martin R, Emo Research Group. Comparison of the Ocular Surface Disease Index and the Symptom Assessment in Dry Eye Questionnaires for Dry Eye Symptom Assessment. Life (Basel). 2023 Sep 21;13(9):1941. doi: 10.3390/life13091941.
- Nattinen J, Aapola U, Nukareddy P, Uusitalo H. Clinical Tear Fluid Proteomics-A Novel Tool in Glaucoma Research. Int J Mol Sci. 2022 Jul 23;23(15):8136. doi: 10.3390/ijms23158136.
- Korenfeld M, Nichols KK, Goldberg D, Evans D, Sall K, Foulks G, Coultas S, Brazzell K. Safety of KPI-121 Ophthalmic Suspension 0.25% in Patients With Dry Eye Disease: A Pooled Analysis of 4 Multicenter, Randomized, Vehicle-Controlled Studies. Cornea. 2021 May 1;40(5):564-570. doi: 10.1097/ICO.0000000000002452.
- Brinkman D, McSwiney T, James M. Comparing the tolerability of preservative-free tafluprost versus preserved latanoprost in the management of glaucoma and ocular hypertension - an observer blinded active-control trial. Ir J Med Sci. 2024 Oct;193(5):2589-2595. doi: 10.1007/s11845-024-03704-7. Epub 2024 May 15.
- Tapply I, Broadway DC. Improving Adherence to Topical Medication in Patients with Glaucoma. Patient Prefer Adherence. 2021 Jul 2;15:1477-1489. doi: 10.2147/PPA.S264926. eCollection 2021.
- Fea AM, Vallino V, Cossu M, Marica V, Novarese C, Reibaldi M, Petrillo F. Drug Delivery Systems for Glaucoma: A Narrative Review. Pharmaceuticals (Basel). 2024 Sep 2;17(9):1163. doi: 10.3390/ph17091163.
- Bacharach J, McLaurin EB, Silverstein S, Amrane M, Garrigue JS, Ismail D, Flynn WJ; Catiolanze Phase 2 study group. Efficacy and Safety of a Preservative-Free Latanoprost Cationic Emulsion in Patients with Open-Angle Glaucoma and Concurrent Ocular Surface Disease: A Randomized Phase 2 Study. J Ocul Pharmacol Ther. 2024 Nov;40(9):553-561. doi: 10.1089/jop.2024.0029. Epub 2024 Aug 16.
- Tauber J, Evans D, Segal B, Li XY, Shen W, Lu C, Novack GD; VVN001-CS201 Study Group. A phase 2a, double-masked, randomized, vehicle-controlled trial of VVN001 in subjects with dry eye disease. Ocul Surf. 2023 Apr;28:18-24. doi: 10.1016/j.jtos.2022.12.007. Epub 2022 Dec 29.
- Muz OE, Dagdelen K, Pirdal T, Guler M. Comparison of BAK-preserved latanoprost and polyquad-preserved travoprost on ocular surface parameters in patients with glaucoma and ocular hypertension. Int Ophthalmol. 2021 Nov;41(11):3825-3835. doi: 10.1007/s10792-021-01947-2. Epub 2021 Jul 14.
- Nijm LM, Schweitzer J, Gould Blackmore J. Glaucoma and Dry Eye Disease: Opportunity to Assess and Treat. Clin Ophthalmol. 2023 Oct 17;17:3063-3076. doi: 10.2147/OPTH.S420932. eCollection 2023.
- Uche NJ, Udeh NN, Chuka-Okosa CM, Kizor-Akaraiwe NN, Uche EO. Glaucoma care and follow-up in sub-Saharan Africa: Is there a need for modification of counselling practices to improve awareness, knowledge and treatment acceptance profiles? A prospective cross-sectional study. Int Ophthalmol. 2020 Jun;40(6):1539-1546. doi: 10.1007/s10792-020-01323-6. Epub 2020 Feb 22.
- Lopes NLV, Gracitelli CPB, Chalita MR, de Faria NVL. Ocular Surface Evaluation After the Substitution of Benzalkonium Chloride Preserved Prostaglandin Eye Drops by a Preservative-free Prostaglandin Analogue. Med Hypothesis Discov Innov Ophthalmol. 2019 Spring;8(1):52-56.
- Siesky B, Harris A, Belamkar A, Zukerman R, Horn A, Verticchio Vercellin A, Mendoza KA, Sidoti PA, Oddone F. Glaucoma Treatment Outcomes in Open Angle Glaucoma Patients of African Descent. J Glaucoma. 2022 Jul 1;31(7):479-487. doi: 10.1097/IJG.0000000000002027. Epub 2022 Mar 29.
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- Labbe A, Terry O, Brasnu E, Van Went C, Baudouin C. Tear film osmolarity in patients treated for glaucoma or ocular hypertension. Cornea. 2012 Sep;31(9):994-9. doi: 10.1097/ICO.0b013e31823f8cb6.
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Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- CEI-002
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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